Four IVD Devices Influenced by Consumerization

The design of IVD devices, especially those intended for use at the point of care or at home, is getting sleeker, more compact, and more intuitive: just like that of their consumer-electronic cousins. Occupying a footprint smaller than the proverbial bread box and requiring little, if any, expert knowledge to operate, the IVD devices of today and tomorrow will cause you to draw unavoidable comparisons between them and your personal, handheld electronic devices.

Four such products—three already on the market here in the United States and one recently developed by a venture-capital-backed start-up company—are the iBGStar blood glucose monitoring system by Sanofi, the OraQuick In-Home HIV Test by OraSure Technologies, the Alere INRatio2, and Bio-Meme’s smartphone-based PCR device, respectively.

1. The iBGStar blood glucose monitoring system consists of the iBGStar blood glucose meter and iBGStar Diabetes Manager app and was made commercially available in the United States last summer. Sanofi says the device is the first FDA-cleared blood glucose meter that directly connects to a smartphone and iPod touch. 

Shiv Gaglani, editor of Medgadget, curator of The Smartphone Physical, co-founder of medical-education-technology start-up Osmosis, and speaker on consumer-driven design concepts and developments at the upcoming MD&M Chicago tradeshow and conference says of the iBGStar, “By nature of bringing blood glucose monitoring to the smartphone, it is highly consumerized. Many IVD devices are complicated or relatively inconvenient to use, which is why the smartphone provides a unique opportunity and has led to the mobileization of many of these devices.”

2. OraSure Technologies’ OraQuick In-Home HIV Test is the first over-the-counter home-use rapid HIV test kit to detect the presence of antibodies to human

immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). It is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial and obtain test results within 20 to 40 minutes.

OraSure developed a flip-up laptop design for this test, reminiscent of a notebook or laptop computer. By building the test stand into the actual box, the design “allowed for a more robust testing platform and enabled users to flip through step-by-step instructions as they conducted the test,” write Lucy Sheldon, Karen Unterman, and Mick Withers in an MD+DI article on home-use IVDs. Another change implemented was the modification of the developer vial cap. “This was altered to add thumb indentations to the cap, making it easier for the consumer to open the vial without spilling the solution,” Sheldon, Unterman, and Withers add.

3. After Medicare approved home PT/INR use in 2009, new consumerized versions of PT/INR meters were designed to

transmit data wirelessly to computers and, ultimately, physicians. The resultant Alere INRatio2 device for anticoagulation management is small, unintimidating, and reminiscent of an iPod in its user interface. A fingerstick sample is placed on a test strip that performs both the test and the quality controls, and results are provided in about one minute.

(Alere also just this month received FDA approval to market its Determine HIV 1/2 Ag/Ab Combo for the detection of HIV-1 p24 antigen and antibodies to HIV-1/HIV-2.  The lateral-flow test is the first and only FDA-approved rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies.)

4. On the horizon, and possibly representing the future of molecular diagnostics, is an IVD device currently in development that acts as a smartphone-based PCR machine for point-of-care diagnostics. The device, by start-up Biomeme and brought to my attention by Gaglani, “turns your smartphone into a

convenient, low-cost lab for quick DNA diagnostics and on-site disease tracking,” according to Biomeme’s website. Among its many potential benefits touted on the site are mobility, professional-caliber DNA lab diagnostics at low cost, connectivity, accuracy via qPCR, and ease of use.

Writer Chris Velazco of TechCrunch.com describes the operation of the device this way:

—Maureen Kingsley

See Shiv Gaglani's talk on consumerization in medical technology live and in person; register for MDM Chicago Exposition & Conference here.